Analytics That Matter in Biosimilar Development

In this episode of Chromatography Life podcast, host Neil Lander sits down with longtime colleague Tracy Hibbs, Principal Consulting Product Marketing Manager at Waters Corporation, to discuss quality risk management. Tracy brings an abundance of knowledge in the world of chromatography, from her extensive background in the topic to her comprehensive career at Waters, and leans into her vast expertise in risk identification and management. They discuss where to begin with risk management, explain the benefits of being proactive instead of reactive in identifying potential risks, and provide resources on the topic. Tune in now to hear the full discussion.

In this episode of Chromatography Life podcast, host Neil Lander sits down with Heather Longden, an Independent Regulatory Consultant in the pharmaceutical industry, who specializes in data integrity, regulatory compliance, data management, and GLP, GNP, and computer system validation. She acts as an advisor to various regulatory groups and serves on numerous regulatory boards. This conversation covers what has changed in the areas of validation and qualification over the last few years, exploring current events in the pharmaceutical industry and with the FDA. Tune in to hear the full discussion.

In this episode of Chromatography Life podcast, join us for a deep dive into the world of gel permeation chromatography (GPC). Host Neil Lander sits down with GPC expert Larry Meeker, who brings more than 27 years of hands‑on experience at Waters Corporation. From helping customers master method development to supporting everyday GPC workflows, Larry has seen it all. In this episode, the two explore how GPC has evolved over the years, unpacking advances in instrumentation, shifts in column chemistry, and the growing role of chromatography software. Whether you're new to GPC or a seasoned practitioner, this conversation is packed with insights you won't want to miss. Tune in now to hear the full discussion.

In this episode of Chromatography Life, Neil Lander and Colette Quinn, Sr. Director of Light Scattering in QC at Waters Corporation break down how the October 2025 FDA draft guidance is reshaping expectations for biosimilar development. They explore why LC and orthogonal techniques like MALS are becoming essential for demonstrating analytical similarity and reducing reliance on clinical studies. Colette also highlights how tools like Empower™ Software support data integrity, reproducibility, and faster development timelines. 

In this special Year in Review episode of Chromatography Life, host Neil Lander reflects on a year of engaging conversations with both Waters colleagues and customers from across the analytical science community. Neil shares what made each episode memorable, from deep technical insights to the personal stories behind the science.

In this episode, Neil Lander sits down with renowned analytical chemist Bob McDowall to explore the complexities of chromatographic peak integration. With over 50 years of experience, Bob shares insights into data integrity, regulatory compliance, and the evolving role of manual vs. automated integration. The conversation dives into real-world examples, AI's potential role in chromatography, and best practices for developing scientifically sound SOPs. 

In our latest episode of Chromatography Life podcast, we explore a fascinating and nearly forgotten separation technique—slalom chromatography—with Dr. Fabrice Gritti, Consulting Scientist at Waters Corporation. Dr. Gritti brings decades of expertise in separation science and shares how this 1980s-era method is being revived to meet today's challenges in DNA and RNA analysis. Dr. Gritti also shares his vision for the future of chromatography, including AI-driven column design and 3D-printed stationary phases.

In Episode 9 of Chromatography Life, we sit down with Richard Verseput, a pioneer in QbD-driven analytical development, to explore how automation, risk assessment, and smart experimental design are revolutionizing chromatography. From cutting-edge tools like Fusion QbD to real-world strategies for building robust, adaptable methods, this episode is packed with insights that can transform your lab's efficiency and precision. Whether you're optimizing LC-MS workflows or navigating regulatory expectations, this is a must-listen for every analytical scientist.

Join host Neil Lander as he sits down with Peter Baker, President of Live Oak Quality Assurance and former FDA Investigator of the Year, to explore the complexities of equilibration injections in regulated laboratories. Peter shares his global regulatory experience, offering insights into data integrity, risk management, and how to avoid common compliance pitfalls. This episode is a must-listen for those navigating regulatory expectations in analytical labs.

Join host Neil Lander as he sits down with Margaret Maziarz, Principal Scientist at Waters Corporation, to discuss the latest tools and strategic approaches to optimizing method development. Margaret guides us through the advantages to various types of instrumentation, the importance of selecting the right column chemistry, and the powerful capabilities of Empower software. She highlights the critical role of monitoring method performance over time and the challenges of transferring methods between LC systems. For those looking for a quick dose of method development expertise, this episode is a must-listen.